United States
Environmental Protection
Agency
Pollution Prevention
and Toxics
(7407)
Spring/Summer 1997
EPA749-R-97-001a
Chemicals in the Environment
Public Access Information
International
Chemicals
Management
U.S. EPA Leadership Strengthens International
Environmental Safeguards
Lynn R. Goldman, M.D., Assistant Administrator
U.S. EPA Office of Prevention, Pesticides and Toxic Substances
In the global village of ecology and trade, the U.S.
Environmental Protection Agency (EPA) is taking a
lead role in strengthening safeguards for human health
and the environment.
U.S. leadership is vital. Pollution knows no
boundaries, jeopardizing the Earth's interconnected
support system of air, water, and land. A world with a
depleted stratospheric ozone layer, significant climate
change, water shortages, contaminated drinking water,
overpopulation, overdependence on fossil fuels,
desertification, and loss of biodiversity is inherently
unstable.
International work on chemicals occurs within this
context. The pace of development worldwide,
including the use of chemicals, is accelerating many of
these processes. Chemicals can provide many benefits
and are part of development, but there are risks when
the management and use are not sustainable. As the
largest net exporter of chemicals in the world, the
United States has a responsibility to share its expertise
on toxic chemicals with other nations as a matter of
public health and environmental protection and national
security.
The agreement signed April 7 by EPA Administrator
Carol M. Browner and Canadian Minister of the
Environment Sergio Marchi to coordinate plans to
virtually eliminate persistent toxic substances in the
Great Lakes is the latest in a series of international
measures to increase public health and environmental
protection.
In concert with the State Department and other U.S.
agencies, EPA is contributing to significant
environmental advances through an array of
international efforts, including the Intergovernmental
Forum on Chemical Safely (IFCS), created in 1994 in
response to a recommendation by the U.N. Conference
on Environment and Development (UNCED) in Rio de
Janeiro. The IFCS serves as the over-arching global
body for promoting the environmentally sound
management of chemicals.
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Chemicals in the Environment
Spring/Summer 1997
Contents
U.S. EPA Leadership Strengthens
International Environmental Safeguards
Dr. Lynn Goldman
A Global Strategy for Chemical Safety
A New Generation of International
Cooperation on Dangerous Chemicals
tINEP Chemicals: The United: Nations
Environment Programme's Chemical
Management Program
Environmental Issues Raised by International
Trade Rules
Harmonization of Classification and labeling
Systems
The OECD's Environmental Health and Safety
Program
EPA/OECD Test Guidelines Harmonization
ISO 14000 Environmental Management
Standards , .
Pollutant Release and Transfer Registers:
International Toxics Release Inventories
The Commission for Environmental
Cooperation: A North American Approach to
Environmental Concerns
Governments as Green Customers
Non-Regulatory Initiatives and the Use of
Ousters for Chemical Risk Reduction: An
The Four-Corners Agreement: The U*S. and
Canada Share Information on New
Chemicals
Measuring Air Pollution in the Great Lakes
Region
International Toxicologieal Profiles
Chemicals in the Environment: fabJie Access
Information is published by EPA*s Office of PoSuiion
Prevention ana Toxscs (OPPT) to increase public
awareness of and access to infoaaaiioH qn toxle
chemicals and pollution prevention available through
OPPT. This resource is also available on the World WMe
Web at nttp;//w\¥W,epa.goy/cie/
Mailing address: Chemicals in the Environment Public
Access Information, U. S. EPA, Office of Pollution
Prevention and Toxics (7407), 401 M St, S.W.,
Washington, DC 20460.
Advisory Board
Project Manager. Georgianne McDonald
Publisher. Randall Brinkhuis
Senior Editors: Odelia Funke, GeorgianneMcDonald
OPPT Divisional Representatives:
David DiFiore, CCD; Denise Kearnsj CMD; Dan Fort,
EETD; Odelia Funke, 1MD; Ruth Heikkineu, PPD;
Randall Brinkhuis, CSRAD; Mike McDoneB, EADjLetty
Tahan, HERD. [Note: OPPT was recently reorganized
(effective April 13, 1997). The Chemical Screening and
Risk Assessment Division (CSRAD) and the Health
Effects Review Division (HERD) merged to become fee
Risk Assessment Division (RAD). The Chemical
Management Division (CMD) was renamed the National
Program Chemicals Division (NPCD)J[
OPPTS is the National Focal Point for
Chemicals Management in the United States
EPA's Office of Prevention, Pesticides and Toxic
Substances (OPPTS) led the U.S. delegation at the
creation of IFCS and serves on its Intersessional Group
and Standing Committee, which help guide its actions.
The Department of State has identified OPPTS as the
National Focal Point for chemicals management in the
United States, giving this office the responsibility for
coordination of technical issues across all U.S. agencies
that are responsible for chemicals management.
Coordinated international action is critical for dealing
with international problems, and important strides are
being made. In January, the Governing Council of the
United Nations Environment Program (UNEP), with
strong support from the U.S., voted to begin
negotiations on a binding global convention, initially on
twelve persistent organic chemicals.
The U.N. Economic Commission for Europe (UN/ECE)
is developing a protocol under its Convention on Long-
Range Transboundary Air Pollution (LRTAP) to
control persistent organic pollutants, including
pesticides and industrial chemicals and byproducts. It
is developing a second protocol on heavy metals,
focusing on lead, mercury, and cadmium.
The United States is ^•"•^""•^™"™
working with other OPPTS hw the
member countries of the responsibility for
Organization for coordinating
Economic Cooperation technical issues
and Development (OECD) across all K£
and international agencies that are
organizations to encourage f^pOttSiUefor
firm commitments and chemicajs
specific action to reduce _ .
* ., __ management.
unnecessary risks from ^^m^
lead, especially those
involving children. The United States is also exploring
ways through IFCS members to expand lead reduction
globally on a country or regional basis.
With U.S. participation, the international community is
moving to make the voluntary Prior Informed Consent
procedures for banned or severely restricted substances
a legally binding instrument. The procedures are
carried out by UNEP and the U.N. Food and
Agriculture Organization (FAO). They enable all
importing countries to have the opportunity to make an
-------
Issue No. 4
informed decision before accepting or rejecting
pesticides or industrial chemicals on the UNEP/FAO
list of banned or severely restricted chemicals.
Developing countries, in particular, stand to benefit.
International harmonization of programs
Harmonization efforts, such as OECD's Environmental
Health and Safety Program, are bearing fruit. EPA,
through OPPTS, heads the U.S. delegation, and,
because of the Agency's longstanding involvement, the
United States is experiencing environmental and
economic benefits from harmonizing chemical testing
guidelines, promoting Good Laboratory Practices,
sharing testing costs and safety data, and
experiencing faster chemical approvals in
some instances — while respecting
concerns for animal rights.
The OECD Pesticide Forum, created in
1994, ties national pesticide regulators into many
of these ongoing chemical activities and initiates
new harmonization projects specific to pesticides,
including harmonized data submission and data
review formats and risk reduction.
Chemical industry support is needled
But responsibility for sound international
management of chemicals does not rest with
governments alone. The U.S. chemical
industry, as the world's largest exporter of
chemicals, has a responsibility to build global capacity
for protecting public health and the environment
commensurate with its economic impact. In 1995, U.S.
chemical exports worldwide totaled more than $61
billion, according to U.S. Commerce Department data,
up 17.6 percent from 1994.
The industry's support for OECD's testing program for
high-volume-industrial chemicals and participation in
the Chemical Manufacturers Association's Responsible
Care™ program are examples of steps needed.
Action by industry and others to prevent pollution,
reduce risk, and share environmental data to enable
public participation and informed decisionmaking is
key to building the necessary international
infrastructure for sound environmental management and
facilitation of trade.
EPA responded to the recommendation made at
UNCED to strengthen national capacities and
capabilities by working with the IFCS and U.S.
agencies to develop a National Profile on
Management of Chemicals in the United States. The
U.S. National Profile brings together information on all
U.S. chemical safety programs, as well as
representative state and non-governmental activities.
The profile is available on EPA's Web site at:
http://www.epa.gov/opppspsl/profile
International environmental protection underpins
national and international security. It is vital for
continuing growth of environmentally
responsible trade. With EPA engagement in
international efforts discussed in this issue of
Chemicals in the Environment, the United
States is on the right path for sustainable
development and a secure future.
Safeguarding children from environmental health
hazards also needs to be an international priority
in areas ranging from risk assessment and standard-
setting to lead, drinking water, and endocrine-
disrupting chemicals. EPA Administrator Carol
Browner carried this message to the Environment
Ministers' meeting held in advance of the Denver
Summit of the Eight — the G-7 countries and Russia.
The Environment Ministers adopted a resolution
endorsing steps to protect children's environmental
health and urged support by Summit leaders, who, for
the first time, made an explicit commitment to
safeguarding children's health.
The well-being of children living today and generations
to come is at the heart of sustainable development. The
Clinton Administration is strongly committed to
environmental and public health protection, particularly
for children, and this commitment encompasses not
only children in the United States but children around
the world. The direction supported by EPA
Administrator Browner and other Environment
Ministers will contribute to a safer, healthier future for
children.
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Chemicals in the Environment
Spring/Summer 1997
A Global Strategy for Chemical Safety
Diane D. Beal, Ph.D., Deputy Counselor for International Affairs, OPPTS
In June 1992, the United Nations General
Assembly convened the United Nations
Conference on Environment and
Development (UNCED) to elaborate
strategies and measures to halt and
reverse the effects of environmental
degradation. Among the major outputs of
UNCED is Agenda 21 which is a
blueprint for action in all major
areas affecting the relationship
between the environment and
economy.
Chapter 19 of Agenda 21 lays
out the current global strategy to
promote chemical safety.
Specifically, it contains six
program areas which are meant to
ensure the environmentally sound
management of chemicals and calls for the
establishment of an intergovernmental forum on
chemical safety and coordination of the efforts between
international organizations working on chemicals.
The six program areas recommended in Chapter 19 are:
(1) the expansion and acceleration of international
assessment of chemical risks;
(2) the harmonization of classification and labeling of
chemicals;
(3) information exchange on toxic chemicals and
chemical risks;
(4) establishment of risk reduction programs;
(5) the strengthening of national capabilities and
capacities for management of chemicals; and
(6) the prevention of illegal international traffic in
toxic and dangerous products.
UNCED recognized that the successful implementation
of these six program areas is dependent upon intensive
international work and improved coordination of
international activities.
IFCS
The Intergovernmental Forum
for Chemical Safely (IFCS), or
Forum, was created in April of
1994 as the mechanism for
cooperation among governments for the promotion of
chemical risk assessment and the environmentally
sound management of chemicals. The
International Program on Chemical
Safety (IPCS) of the World Health
Organization (WHO) serves as its
Secretariat.
The Forum is a non-institutional
arrangement whereby representatives
of governments meet to consider and to
provide advice and, where appropriate, make
recommendation to governments, international
organizations, intergovernmental bodies, and non-
governmental organizations involved in chemicals. In
fact, it works closely with these different bodies to
integrate and consolidate efforts to promote chemical
safety and to establish Priorities for Action which
indicate immediate actions and long-term goals
necessary to accomplish the six program areas listed
above.
The Inter-Organization Programme for the Sound
Management of Chemicals (IOMC) was established in
1995 by the United Nations Environment Programme,
International Labor Organization, World Health
Organization, Food and Agriculture Organization,
United Nations Industrial Development Organization,
and Organization for Economic Cooperation and
Development following recommendations made by
UNCED. Later, the United Nations Institute for
Training and Research became a participating
member. The purpose of the IOMC is to strengthen
cooperation and increase international coordination in
the field of chemical safety. These organizations
working together help implement the
recommendations in Chapter 19 of Agenda 21 as laid
out in the Priorities for Action.
4
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Issue No. 4
CEC
CG/HCCS
EMSs' '
EPOC
Etf
FAD
FIFJBA ,,
C3JJP ,
OLPs
IADN
IFCS
IOMC
IPGS
IRPTC
LRTAP
MRA.
MSWG
NAFTA
NPRI
O3ECD
OFF
OPPT
OPPTS
PIC
POP&
PPD
PKIK&
RETC
TRI
TSCA"
CNCETDG
UNEP
UNITAR
WHO
Abbreviations Used in TSis Issue
Comttussion fer Environmental Cooperation
Ceordinadag<5roup foFfieHafflionizatioii of Chemicals Classification Systems
Envtremiaental Management Standards
.Federal Iaseetkade,Fungicide, aadRo
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Chemicals in the Environment
Spring/Summer 1997
A "New Generation" of International Cooperation on Dangerous
Chemicals
l.L. "Pep" Fuller, Counselor for International Affairs, OPPTS
Introduction
In recent years, policymakers have increasingly
recognized the global and transboundary dimensions of
harms posed by the manufacture, use and trade of
dangerous chemicals and substances. These harms,
which affect both humans and wildlife, result from:
contamination of shared resources, such as air or
watersheds; migration across boundaries of "persistent
substances" such as PCBs or DDT that do not break
down quickly in the environment; exposure of
farmworkers to dangerous pesticides; and the
possibility of pesticide residues hi international food
supplies.
Governments have been working
together on certain chemicals issues
for many years, as illustrated by the
Organisation for Economic
Cooperation and Development (OECD) Chemicals
Programme, which began in the early 1980's, and the
UNEP-FAO Voluntary Guidelines for Prior Informed
Consent in the trade of chemicals, started in the late
1980's by the United Nations Environment Programme
(UNEP) and the UN Food and Agriculture
Organization (FAO).
The 1992 United Nations Conference on Environment
and Development (UNCED), more commonly referred
to as the Earth Summit, marked a major step forward in
this area. In particular, Chapter 19 of the Earth
Summit's Agenda 21 —the "blueprint?' for action on
sustainable development in the 21st century — sets
forth a broad new international agenda for the
environmentally sound management of chemicals.
In the years since the Earth Summit, two initiatives
have risen to the top of the international chemicals
agenda: the development of a legally binding
international agreement on Prior Informed Consent
(PIC); and the development of a legally binding
international agreement on Persistent Organic
Pollutants (POPs). The negotiation of these new
agreements is being accompanied by a variety of
parallel, and hopefully complementary, regional
actions. Governments also have joined together to
establish a new institutional structure to help
coordinate these efforts, including the new
Intergovernmental Forum for Chemical Safety (IFCS).
Negotiation of a New Agreement on Prior Informed
Consent
The United States and other countries have participated
for many years hi a voluntary system of Prior Informed
Consent (PIC) for pesticides and industrial chemicals
that are banned or severely restricted at the national
level. In essence, the PIC system provides that the
governments of countries exporting PIC-listed pesticides
or chemicals must provide prior notice to, and receive
consent from, the governments of countries into which
those pesticides or chemicals are to be imported.
The voluntary system began hi the OECD. It evolved
and was later opened to all countries under the joint
sponsorship of UNEP and the FAO. The system has
been widely embraced and now includes some 120
countries. It is designed to enhance information flow
regarding regulatory actions taken by nations, and to
ensure that importing countries have the opportunity to
make informed decisions on whether or not to receive a
substance that has been banned or severely restricted
elsewhere. This is especially important given the large
volumes of international trade in
dangerous pesticides and chemicals,
and the lack of well-developed
regulatory structures in many
countries involved in this trade.
A major purpose of the PIC is to provide technical
support to countries, in particular developing countries
that do no yet have adequate infrastructure to perform
sophisticated risk assessments. In effect, the PIC
process acts as a collective risk assessment mechanism
for priority substances. In addition, by calling upon
exporting countries to refrain from export in the absence
of notice and consent, the PIC system reinforces the
ability of importing countries (that lack infrastructure)
to enforce decisions they may take regarding substances
entering their countries.
In May 1995, the UNEP Governing Council called for
negotiations to transform the existing, voluntary PIC
system into a legally binding agreement. This decision
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Issue No. 4
Public Access Information
builds upon earlier pronouncements of Agenda 21, the
UN Commission on Sustainable Development, and the
EFCS. To date, countries have held several negotiating
sessions to develop a final PIC Agreement. These
negotiations build upon technical documents developed
in meetings of experts in Geneva in 1994-1995.
The negotiations have raised some
important issues. These include, for
example: What type of process
should be required before a substance
is included on the PIC-list? Is it
enough if it is banned by one country only? By five
countries? Does it need to be reviewed by an
international expert body? Or only by the interested
Parties? Under what voting procedures? What should
be the balance of rights and obligations between
importing and exporting countries? These and similar
questions are expected to be dealt with in negotiations
that should conclude within the next year.
The United States has been actively involved in the
negotiations, with representation from EPA's Office of
Prevention, Pesticides and Toxic Substances (OPPTS)
as well as EPA's Office of General Counsel (OGC).
This involvement is critical, in part because the
negotiations will affect both the Toxic Substances
Control Act (TSCA) and the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) since they do
not require consent for export of covered products
(although both laws do have certain notice provisions).
Under both TSCA and FIFRA the United States has a
long experience in notifying other nations of regulatory
actions regarding industrial chemicals, issuing
thousands of notifications. This experience suggests
certain conclusions:
• For nations with inadequate infrastructure, more
information can be important but does not
automatically lead to better results.
• If a country does not have the capability to make its
own detailed risk assessments, it may wish to rely
on those assessments made by countries which
possess such capabilities. In many cases, this will
be an important way to support the efforts of those
countries. Nevertheless, in some cases, this may
not produce the best environmental or health result
since different climatic or soil conditions, flora and
fauna, disease vectors and conditions of use can
result in different outcomes. Reliance on
information from other countries cannot be a
complete substitute for developing appropriate
** infrastructure for a country or a region..
For example, specific requirements on continued
use of a pesticide in the U.S., such as the use of
protective clothing or respirators may not be
available in a developing country. As a result,
approval for use in that country might create risks
not present in the United States.
• In view of the lack of infrastructure in many
countries, it is of critical importance to concentrate
the PIC process on those chemicals which pose
serious threats to health or the environment.
Information on chemicals which have been
regulated anywhere should be made available
internationally, but not necessarily as part of the
mandatory PIC process. Otherwise the process
could swamp a country's available resources.
As is generally the case under international agreements,
the U.S. will use domestic laws and regulations as the
primary basis to achieve implementation at the domestic
level. Given mat FIFRA and TSCA do not now require
both notice and consent procedures prior to export,
careful attention will be needed to ensure that sufficient
domestic authority exists to implement the anticipated
PIC agreement, and that actions are undertaken in a
transparent and open process.
Regional actions taken on
chemical safety
Some of the regional actions taken, under
international auspices include:
» the negotiation of Protocols m. Persistent
Organic Pollutants (POPs) and. heavy
metala under: the United Nations Economic
Commission for Europe (UN/ECB)
Convention on Long Range Transport of
Air Pollution (LRTAP);
• the 1995 Resolution for Environmeatally
Sound Management of Chemicals under the
North American Commission for
Environmental Cooperation (CEC); and
* the Joint IXS.-Canada Binational Strategy
for Virtual Elimination of Persistent Toxic
Substances in the Great Lakes Basin.
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Chemicals in the Environment
Spring/Summer 1997
Negotiation of a New Agreement on Persistent
Organic Pollutants (POPs)
In parallel to the negotiation of an agreement on Prior
Informed Consent, nations have recently committed to
negotiate a set of stringent controls on a short list of
especially dangerous chemicals and substances known
as persistent organic pollutants, or POPs.
Discussions within the United Nations Economic
Commission for Europe (UN/ECE) in the early
1990's provided an important
stimulus for international
cooperation on POPs. Experts
have undertaken much valuable
work in this forum, including on
criteria for selection of POPs. Indeed,
the current United Nations short-list of 12
POPs for initial action was derived in large
measure from these efforts. The UN/ECE
countries are now negotiating a POPs Protocol to
the 1979 UN/ECE Agreement on Long Range
Transport of Air Pollutants (LRTAP).
In 1994, the meetings of the UN Commission for
Sustainable Development helped bring these issues to
a more global forum. In a key meeting in Manila in
1996, experts of the IFCS developed a series of
conclusions and recommendations regarding the
development of a global POPs agreement, that were
forwarded on to the UNEP Governing Council. In
January-February, 1997, the UNEP Governing Council
formally approved the negotiation of a legally binding
instrument on POPs, picking up many of the points
developed at the Manila meeting.
The POPs agreement is expected to go beyond
provisions for notice and consent in the context of
trade, and focus more directly on production and use.
At the 1996 meeting in Manila, the IFCS recommended,
among other things, that the POPs instrument provide
for the phasing out of the production and use of
intentionally produced POPs, subject to narrow
provisions relating to available alternatives and
recognized uses. It also called for strong measures to be
developed to address unintentionally produced POPs
such as dioxins and furans.
The POPs negotiations are likely to
raise a number of challenging issues,
including: the precise nature of the
control obligations on the initial list
(for example, how to address the
still existing use of DDT to combat
malaria?); the criteria and voting
structure for adding new substances to
the list; the use of trade/export
controls; provisions for technical
cooperation and support to implement
the agreement (especially for developing countries);
and provisions to address existing stockpiles of POPs.
At the domestic level, the U.S. will need to examine
closely its legislative authorities as it develops its
measures and actions for implementation. One question
of particular significance relates to possible production
bans or controls on POPs-listed pesticides. As currently
structured, FIFRA does not provide the domestic legal
authority to ban the manufacture of pesticides for
export.
A separate challenge — and opportunity — will be to
coordinate the multilateral POPs effort with other
initiatives at the regional level, including the UN ECE
POPs Protocol and actions under the North American
Commission for Environmental Cooperation Resolution
on the Sound Management of Chemicals.
Persistent Organic Pollutants (POPs) Recognized by
the United Nations Environment Programme (UNEP)
Aldrin
Chlordane
DDT
Dieldrin
DioxCns and furans
Endrin
Heptachlor
Hexachforobenzene
Mlrex
PofychJorinated btphenyJs
(PCBs)
Toxaphene
From one perspective, these
initiatives will offer an
opportunity to elaborate on
the commitments developed
at the global level, and
translate them into concrete
measures to achieve
implementation.
8
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Issue No. 4
UNEP Chemicals: The United Nations Environment Programme's
Hazardous Chemicals Management Program
James Willis, Director, UNEP Chemicals
UNEP Chemicals is the center for all activities
undertaken by the United Nations Environment
Programme (UNEP) to ensure the global sound
management of hazardous chemicals. Located in
Geneva, Switzerland, it is built upon the solid technical
foundation of the International Register of Potentially
Toxic Chemicals (IRPTC).
UNEP Chemicals' main functions are to promote
chemical safely by providing countries with access to
information on toxic chemicals, by assisting countries
in building their capacities to produce, use, and dispose
of chemicals safely, and by facilitating global actions
that may be needed to reduce or eliminate chemical
risks.
Chemicals are essential for continued economic
development. Globally, production and trade in
chemicals is measured in the trillions of dollars.
Chemical production or use is a crucial component of
virtually every sector of our economies, and all of us in
some way come into daily contact with chemicals.
While most of these chemicals are benign at the levels
to which people are usually exposed, others present
risks to human health and the environment.
In the case of chemicals, sustainable development
means the continuation of global production and use of
chemicals, while at the same time reducing or
eliminating unsustainable risks from those chemicals or
activities.
Sustainable development requires a global capacity for
the sound management of chemicals. National
capacities exist within most industrial countries, but
usually to a more limited extent elsewhere. One
component of building global capacity is to extend the
sound management of chemicals to all countries; that
is, to take steps to ensure that all countries have the
needed information, expertise, and resources to manage
chemicals safely under the conditions of production or
use in that country.
The other facet of global capacity is ensuring that the
necessary global actions are taken to address risks that
are not captured by national actions alone. Certain
aspects of commerce, use, or environmental release of
chemicals requires concerted global action to ensure
risks are sufficiently reduced. Achieving these goals
requires a global chemicals program.
The most important UNEP actions during 1997 to
catalyze global action for the sound management of
chemicals are:
Facilitating development of a legally binding instrument
for the application of the Prior Informed Consent (PIC)
procedure. Negotiations have begun, convened by
UNEP jointly with the Food and Agriculture
Organization (FAO), and are expected to conclude by
the end of 1997. The existing voluntary PIC program
implemented by UNEP and FAO under the London
Guidelines and the FAO Code of Conduct will continue
pending development of the legally binding instrument.
Convening an intergovernmental negotiating committee
for the development of a legally binding instrument to
implement international action on Persistent Organic
Pollutants (POPs). In addition to facilitating the
development of a global POPs convention, UNEP is
undertaking immediate action on a number of measures
to help address persistent toxic chemicals into the
environment.
These measures include promoting the exchange of
information and expertise among governments on
POPs; providing guidance on alternatives to POPs;
assisting countries in the identification of
polychlorinated biphenyls (PCBs), including those
in use, in stockpiles, and in waste, as well as helping
to identify where PCBs can be destroyed safely;
assisting countries in identifying sources of dioxin
and furan releases; and continuing to better
characterize the full extent of the global POPs
problem.
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Chemicals in the Environment
Spring/Summer 1997
In the field of capacity building, UNEP Chemicals'
work is implemented in two key areas:
Promoting information access through the delivery
of information and information tools for countries to
use in assessing and managing the risks of
chemicals. Activities hi this area include:
• ERPTC's databank, which is available in a
personal computer version that contains
extensive safety data on over 8,000 chemicals;
• Internet and hard-copy information
clearinghouses on chemical hazards, pollutant
release and transfer registers (PRTRs), POPs,
and PIC;
• published inventories of information sources
covering international data sources on chemicals,
critical reviews of chemicals, new chemical
assessments (in progress), and national data on
existing chemicals (in progress); and
• extensive publications in the field of chemical
safety.
Direct work with countries in building capacities,
including awareness raising, training, capacity
building exercises, and hotline support for
governments. UNEP actively sponsors or
participates in over 20 capacity building workshops
on chemicals management each year. These take
place on the regional, sub-regional, and national
level, and cover such diverse topics as risk
assessment, development of national information
systems, chemicals legislation, and operation of the
PIC procedure.
i United Nations Environment Programme
' Programma des Nations Unles pour rEnvironnemerrt
More information on the UNEP Chemicals Programme can be obtained by contacting:
Mr. James B. Willis, Director
UNEP Chemicals (ffiPTC)
15 Chemin des Anemones
Case Postale 356
CH-1219, Chatelaine
Geneva, Switzerland
Telephone: 41229799111
Telefax:: 41 22 797 3460
E-Mail: irptc@unep.ch
Homepage: http://irptc.unep.ch/irptc/
Environmental Issues Raised by International Trade Rules
Peter L. Lallas, Office of General Counsel, International Environmental Law Office
In recent years, a number of events have served to
demonstrate the strong, and not always harmonious,
connection between international trade and
environmental protection. The initial catalysing event
was the 1991 decision of an international dispute panel
that provisions of the U.S. Marine Mammal Protection
Act violated international trade rules (the so-called
Tuna-Dolphin decision). The question of the
relationship between trade rules and environmental
protection also was prominent in the negotiation of the
North American Free Trade Agreement (NAFTA) and
related environmental instruments (1992-1993), and in
the negotiation of a new set of world trade agreements
in the so-called Uruguay Round of multilateral trade
negotiations (concluding in 1994).
The new trade agreements, in particular, contain a
number of important and legally-binding provisions of
potential relevance to environmental policy. Subject to
certain exceptions, these include the following:
• Non-Discrimination: A country may not
"discriminate" against imported products by giving
them less favorable treatment than the "like"
domestic product, or less favorable treatment than
10
-------
Issue No. 4
that accorded to products from "most-favored-
nation" trading partners;
No Quantitative Restrictions: A country may
not impose restrictions on the quantity of
imported products;
No More Trade Restrictive than Required: A
country must ensure that product standards and
food safety measures are "not more trade
pbjective (as defined);
Us^ - ~ __
|uct standards and food safety measures must
"based on "international standards," except
; international standard fails to meet the
Questions also have been raised about whether trade
restrictions connected with international environmental
agreements, such as the Montreal Protocol restrictions
on trade with non-parties or provisions of the Basel
Convention on the Transboundary Movements of
Hazardous Wastes and Their Disposal, might run into
conflict with the trade rules. Similar questions could
arise in the context of future anticipated agreements,
such as a new international agreement on Prior Informed
Consent (PIC) procedures for certa^S^eTproducts
and^ROPs
agreements, page six].
. „ „„ ^^ ^ U1W1- m^ Other environmental concernsjvith respect
's own legitimate objectives (including its should also be noted. Ctae^Jwhemer i
"triA** tj-«r.i-»1 n.-C*«.A.f-AAJ^ \. flfWn/YfYltr» m^rtTirfk 1v*t1fA«4 4-* -fc-Jijl — t*f »*^* .1*
i chosen level of protection);
|nce and Risk Assessment for Food Safety
sures: A country's food safely measures
m i be based on a risk assessment, and not be
faalntained without "sufficient
be
economic growth linked to ^v^^^uuii wm oe
environmentally-sound (suclL.as,, "for examp%, new
economic activity in ftf TJ.S.-Ktexicp border areaTaiked
to NAFTA). Anothli^whejpr frade and ecMmic
scientific integration might leaBi t6so-$ ^JA-^^i****2-J_ t J. XtJ* N.
prof-ides a possible defense against challenges to
1 measures under the various trade rules.
Froml
concern
applied
(or 01
envir
Igelerally
Thesl iriplude,
or pesticides du
restribtilns on
. J .. i
. ,. • °n
emissio
tradeirules are desi
andim
issues,
, ~
lons'arfr n
vss' 3¥^***c?- «g? «» * ^^^*^i * & ^^^%
environmental policy perspective; thejfe Is the^ envirbttmeaital
•*— these and oliejt.rtrade rules"mISht be ^inciu^the^J^Es
what
|lde rules toj
concerns. Thes
1 «&»„ < tM %
Cpmniiitee 8n T;
.QrgaVnsation for EC;
,
p on Sus&i^able|»eveiopment.
J l*3S I
>-,T^4 » - ^
lPAW^ pjayecTJcey rofes
discussions. J%e^joTned,(iirf otfy in the pegotaion of
ade ^"4 "l^&ilpsmentejvhere they to
., 'P^W1 and slreqg^ien^,^ negotmting positio^n the
fved,fbelefficiency,*HBecaiiseitne JMFTA^d.thellmg&ayJRDund. EPA las aS been
iedtoremov^"J>arrierstotade," instrumental in developing the overall U.St policy
* fi^fwoifc-toltdaresl iehese issues. Key elements have
b,eett^c6iupletioi» of env,irc>rii5ie»tal rej:iews,bf Jrade
agreements; negotiation of provisions in trade
agreeements to safeguard the integrity of environmental
policy measures; development of environmental
initiatives, in parallel to trade initiatives, to address the
types of concerns noted above; direct involvement of
environmental officials in trade discussions and
negotiations; and public involvement.
legal obligaS
^^^^J*^f^^^^^™"» - ^-^
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Chemicals in the Environment
Spring/Summer 1997
EPA officials continue to engage in new
initiatives. These include, among others: the
negotiation of a new Multilateral
Agreement on Investment (MAI) in
the OECD; negotiations on the
subject of Mutual Recognition
Agreements between the U.S. and
the European Union; and trade and
environment issues relevant to the negotiation of the
new PIC agreement and other international instruments.
At the domestic level, EPA has developed a greatly
increased capacity to analyze and respond to
environment and trade issues as they arise. There
exists an Agency-wide Task Force on Environment
and Trade, dedicated to addressing these issues.
Several EPA offices, including the Office of
Prevention, Pesticides, and Toxic Substances,
participate actively hi this work. Within the EPA
Office of General Counsel, there is an Environment
and Trade Team designed to support the activities of
the Task Force and strengthen the ability of the
Agency to address connections between EPA initiatives
and the trade agreements. Recently, this team
developed a checklist item that is now included in the
EPA Regulation Tiering Form,
which provides guidance to
regulation-development teams on the
types of questions they need to consider
to hi light of existing trade rules as they develop
their regulations.
The trade and environment debate is a complex one.
Internationally, important differences remain among
countries hi how they view the connection between
environmental protection and removing barriers to trade.
Many countries remain steadfastly opposed to any
modifications that might "weaken" the stringency of the
trade rules in response to certain environmental policy
concerns. Domestically, there remains the challenge of
finding the right balance to promote underlying policy
objectives, of abiding by our international obligations,
and of ensuring that the inexorable movement toward a
more global economy, characterized by open trade and
economic integration, occurs in a manner consistent
with environmental policy objectives, in support of
sustainable development. There has been important
progress toward common ground, but it is not an easy
path.
Harmonization of Classification and Labeling Systems
Diane D. Beal, Ph.D., Deputy Counselor for International Affairs, OPPTS
Many governments, including the U.S. Government,
feel that a uniform way to communicate hazards is
critical as international trade and production increases.
Because of this, governments participating in the
United Nations Conference on
Environment and Development
(UNCED) in 1992 adopted an
international
mandate to pursue a
globally harmonized
classification and labeling
system (Section B, Chapter 19,
Agenda 21). They thought that the
simplest and most efficient way to
indicate how to handle and use
chemicals safely is
i to have proper
labeling of
chemicals and safety data sheets, based on assessed
hazards to health and the environment. They also
recognized that proper classification of chemicals is an
important tool in establishing a labeling system. Their
goal is to have a globally harmonized hazard
classification and compatible labeling system by the
year 2000.
Governments, several international organizations and
many non-governmental organizations are presently
working together on developing such a globally
harmonized system. The Intergovernmental Forum on
Chemical Safety (IFCS) is monitoring and providing
broad guidance while member organizations of the Inter-
Organization Program on Sound Management of
Chemicals (IOMC) are involved in the process of
accomplishing the work. Under the auspices of IOMC,
the Coordinating Group for the Harmonization of
Chemicals Classification Systems (CG/HCCS) is
12
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Issue No. 4
Public Access information
managing the process and is charged with elaborating
the voluntary instrument recommended by the BFCS. It
has adopted a series of principles to guide the work of
the various organizations involved.
The technical work on harmonization is being done by
different international organizations with specific
expertise in the areas involved. The International Labor
Organization (ILO) and the United Nations Committee
of Experts on Transportation of Dangerous Goods
(UNCETDG) are responsible for developing the criteria
for classifying chemicals based on their physical/
chemicals properties; the Organization for Economic
Cooperation and Development (OECD) is responsible
for developing criteria for health and environmental
hazards; and the ILO is responsible for developing the
approach to communicating the hazards.
The U.S. is playing a critical role in this international
effort, including chairing the CG/HCCS. The State
Department coordinates an interagency work group to
develop the United States' position. Members of the
work group include representatives from all of the
agencies that regulate in the area of chemical safety and
health: Environmental Protection Agency (lead office:
OPPTS), Occupational Safety and Health
Administration, Food and Drug Administration,
Department of Transportation, Consumer Product
Safety Commission, and the Food Safety and
Inspection Service. Other agencies that are interested
or involved in trade and policy aspects of the issue also
participate, including the Department of Commence
and the U.S. Trade Representative. The work group has
adopted principles which guide the activities of the
various agencies in the international harmonization
process.
Over the past several years, much progress has been
made with regard to the technical criteria for hazard
classification. Work has also began on development of
a binding instrument in which the harmonized system
could be made available for adoption or ratification by
countries. Consideration is also being given to how to
maintain the system when it is completed. Once the
international system is completed, the U.S. will have to
decide on how the new system will be applied in this
country. The government will need to develop and
consider legal alternatives for adoption of the system.
In fact, legislation may be needed to ensure that all
agencies can adopt the new global system.
For more information
On April 3,1997, a notice concerning U.S. government
activities dealing with international harmonization of
chemical safety and health information was published in
the Federal Register (62 FR15951) as State Department
Public Notice 2526, "Bureau of Oceans and International
Environmental and Scientific Affairs; International
Harmonization of Chemical Safety and Health
Information."
The notice discusses both international and interagency
activities in the area of harmonization of chemical safety
and health information. It lists U.S. goveiment agencies'
guiding principles and international principles for such
harmonization. The deadline for comments was June 2
1997.
For information regarding this notice, please contact:
Trigg Talley, Office of Environmental Policy, U.S
Department of State, OES/ENV Room 4325, 2201 C
Street, NW, Washington, DC, 20520; Telephone: (202)
647-9266, FAX: (202) 647-5947; E-mail:
ttalley@state.gov.
For information about activities of the following groups,
please contact the person listed:
Interorganization Programme for the Sound
Management of Chemicals' (IOMC) Coordinating
Group for the Harmonization of Chemical
Classification Systems: Jennifer Silk, Directorate of
Health Standards Programs, Occupational Safety and
Health Administration, 200 Constitution Avenue,
NW, Room N3718, Washington, DC, 20210;
Telephone: (202) 219-7056; FAX: (202) 219-7068;
E-mail: jsilk@osha-slc.gov.
Organization for Economic Cooperation and
Development's (OECD) Advisory Group on
Harmonization: Amy Rispin, Office of Pesticide
Programs, Environmental Protection Agency,
Washington, DC, 20460; Telephone: (703) 305-
5989; FAX: (703) 305-6244; E-mail:
rispin.amy@epamail.epa.gov.
United Nations' Committee of Experts on the
Transport of Dangerous Goods' (UNCETDG): Frits
Wybenga, Research and Special Programs
Administration, Department of Transportation, 400
7th Street, SW, Washington, DC, 20590, Telephone-
(202) 366-0656; FAX: (202) 366-5713; E-mail:
frits.wybenga@rspa.dot.gov.
13
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Chemicals in the Environment
Spring/Summer 1997
OECD'S Environmental Health and Safety Program
Charles M. Auer, Director, Chemical Control Division, OPPT
The Organization for Economic Cooperation and
Development (OECD) is an intergovernmental
organization which includes 29 democratic countries
with advanced market economies hi Asia, Europe,
North America, and the Pacific. Founded hi 1960, the
OECD promotes: economic growth, employment, and
social welfare hi OECD countries; free trade between
OECD countries and non-member countries; and
economic growth in non-member countries.
OECD's work is overseen by several policy and
administrative bodies. At the highest level is the
OECD Council, made up of ambassadors from OECD
member countries. The Council's main role is to
review and approve the OECD's budget and work
program. It also has the ability to enact Council
Decisions and Council Recommendations. The former
legally bind Member countries to a particular course of
action, while the latter strongly encourage collaborative
action. OECD Decisions and Recommendations are
made by its member countries operating through a
consensus-based process.
At a more technical level, work in the OECD is
directed by specialized committees composed of
representatives from OECD member countries. The
Environmental Health and Safety Program
is directed by the Environment Policy
Committee (EPOC) and the Joint Meeting.
of the Chemicals Group and Management
Committee. Dr. Lynn Goldman, Assistant
Administrator for the Office of Prevention,
Pesticides and Toxic Substances, is the
U.S. Head of Delegation at the Joint
Meeting level.
OECD's Environmental Health and Safety
Program has been working on chemical
safety since 1971. At the outset, the OECD's program
focused on specific industrial chemicals known to pose
significant health or environmental problems, such as
polychlorinated biphenyls (PCBs) and mercury. By the
mid-1970s, however, it became clear that a more
broadly-based approach was needed. The OECD
countries agreed mat a comprehensive, forward-looking
strategy was needed to identify and manage the
potential risks of both new and existing chemicals.
The Program thus began developing methods and tools
that countries could use to assess and manage the risks
of all chemicals. Outstanding examples of these tools
include the OECD Test Guidelines and the OECD
Principles of Good Laboratory Practices (GLPs). In
1981, these formed the basis for the OECD Council
Decision on Mutual Acceptance of Data (MAD).
Under the MAD Decision, test data developed in
accordance with OECD Test Guidelines and GLPs
must be accepted for review by other OECD member
countries.
During the 1980's, new projects were launched to
develop hazard and risk assessment methods,
approaches to risk management, and procedures for
chemical accidents and emergency response. Member
countries also undertook to facilitate information
exchange among themselves.
In the early 1990's, OECD initiated projects to "share
the burden" of testing and assessment of high
production volume chemicals (the Screening
Information Data Set or SIDS program), harmonize
classification and labeling systems, and address the
products of modern biotechnology. The OECD
Pesticide Forum was established to allow pesticide
regulatory authorities in Member countries to discuss
issues of common interest.
One of the OECD's important achievements in this
period was the 1996 Ministerial Declaration calling on
countries to continue and strengthen efforts to reduce
risks from exposure to lead. During this time, the
OECD and its Member countries also joined efforts to
implement the recommendations of Chapter 19 of
Agenda 21 from the 1992 United Nations Conference
on Environment and Development (UNCED) in Rio de
Janeiro.
14 —•
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Issue No. 4
Today, the Environmental Health and Safely Program
continues to support OECD member countries in then-
testing, assessment, and management of chemicals
and pesticides. As the valuable work of the program
has demonstrated, harmonization and international
cooperation remain effective ways to increase
government efficiency, improve health and the
environment, and promote free trade and a healthy
global economy.
Member Countries of the
Organization for Economic Cooperation and Development
(as of early 1997)
Australia
Austria
Belgium
Canada
The Czech Republic
Denmark
Finland -
France
.Germany
Greece
Hungary
Iceland ,
Ireland,
Italy
Japan
The Republic of Korea
Luxembourg
Mexico
The Netherlands
New Zeatend
, Norway
Poland
Portugal
Spain
The European Commission also takes part in the work of the OECB,
Sweden
Switzerland
Turkey
The United Kingdom
The United States
of America
EPA/OECD Test Guidelines Harmonization
Michael C. Cimino, Ph.D., Risk Assessment Division, OPPT
The guidelines harmonization project is a multi-year
effort to harmonize the existing test guidelines of the
Office of Pollution Prevention and Toxics (OPPT) and
of the Office of Pesticides Programs (OPP) into a
single set of guidelines for EPA/OPPTS (Office of
Prevention, Pesticides and Toxic Substances). The
project then harmonizes the OPPTS guidelines with
those of the Organization for Economic Cooperation
and Development (OECD). These guidelines are
important because they set standards for acceptable
testing which EPA and our OECD counterparts may
require of companies when we review chemicals.
International harmonization of test guidelines is a high
priority of the Assistant Administrator for OPPTS. The
goal of such harmonization is to reduce the burden of
repeated testing from chemical companies to meet
differing requirements and to foster international
efficiency of information exchange and mutual
acceptance of test data. The OPPT/OPP project began
in 1991 and is nearing completion. The harmonization
effort with OECD has been ongoing since 1989.
OPPT has published 97 guidelines in the areas of
physical chemistry, ecotoxicity, environmental fate,
and human health. OECD has published 77 guidelines
in the same four areas. OPP has a total of 170 test
guidelines which include guidelines for the above four
areas as well as for other specific requirements for
OPP's evaluation of pesticides (e.g., product identity,
composition, application exposure). Presently, all of
-------
Chemicals in the Environment
Spring/Summer 1997
physical/chemical properties and environmental fate
guidelines, 30 health effects guidelines and six
ecotoxicity test guidelines have been harmonized
between EPA and OECD. Ten health effects guidelines
and 13 ecotoxiciry guidelines have been harmonized
between OPPT and OPP to produce guidelines which
are unique to OPPTS.
Significant advances in scientific knowledge and
methodologies are now being incorporated into the
guidelines. This is particularly true in the areas of
neurotoxicity, developmental neurotoxicity, and
developmental and reproductive biology. OPPT is
currently leading the effort to harmonize these
improved guidelines with OECD.
The OPP Scientific Advisory Panel (SAP) reviewed
ecotoxicity and health effects test guidelines in May
and October 1996, respectively. OPP is revising
these guidelines revised in light of SAP comments.
The revised guidelines will be made available to the
public through the EPA web site or the Government
Printing Office (GPO) web site. Diskettes or hard copy
may also be purchased from GPO.
Cooperative efforts in harmonization between OPPTS
and OECD, as noted above, have been underway for a
number of years. In 1989, OECD gave high priority to
revision of the OECD Guidelines for genetic toxicology
in its "periodical review" process. Guideline proposals
were circulated for review starting in July of 1991.
U.S. experts in the field of genetic toxicology were
given these drafts for comment. After several rounds
of review at the national and international levels,
proceeding concurrently with OPP/OPPT review, the
final proposals were submitted to and endorsed by
OECD. These genetic toxicology guidelines are
currently undergoing translation into French before
official release by the OECD. At that time OECD will
make them available in print form and on the OECD
website at: http://www.oecd.org
The OPPTS Harmonized Test Guidelines can
be found on the EPA web site at:
http://www.epa.gov/OPPTSJLarmonized/ or can
be accessed through GPO Access at:
http://www.access.gpo.gov/ . To order copies from
GPO, call (202) 512-1800.
ISO 14000 Environmental Management Standards
Mary McKiel, Pollution Prevention Division, OPPT
The Pollution Prevention Division (PPD) of the Office
of Pollution Prevention and Toxics (OPPT) is helping
to lead the way for the EPA on the development and
use of the ISO 14000 environmental management
standards (EMSs). ISO 14000 is the name given for a
series of voluntary international environmental
standards, which cover environmental management
systems. These systems govern environmental
auditing, labeling, performance evaluation, life cycle
assessment, and environmental aspects in the setting of
product standards. This article will outline the
potential of these standards to suppport pollution
prevention goals, EPA's formal policy towards ISO
14000, and discuss the opportunities and concerns
OPPT has with the ISO standards.
EPA policy regarding the development of the
ISO 14000 standards
The Voluntary Standards Network was established by
EPA Administrator Carol Browner in 1993 to
coordinate all of the Agency's ISO 14000 activities.
The Offices of Water, Research and Development, and
Enforcement and Compliance Assurance partnered
with the Office of Pollution Prevention and Toxics to
found the Network, which OPPT administers. To
date, there are over 150 members of the Network
representing all of the Offices and Regions.
One of important current undertakings of the Network
is the formulation of a draft EPA formal policy
statement concerning ISO 14000 and EMSs. The
Network's drafting committee has nearly completed
its work and expects the draft policy to be available by
June.
The ISO guidance standards for labeling, life cycle
assessment, and environmental performance
evaluation also have the attention and interest of the
Agency. EPA is represented on each of the ISO
14000 subcommittees through the corresponding U.S.
technical advisory subgroups (subTAGs). Several of
the labeling standards, as well as the life cycle
standards, are almost in the final stages prior to
16
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Issue No. 4
publication. There are some concerns about how these
standards will affect the Agency's efforts underway in
Consumer Labeling as well as positions that EPA
continues to take in the World Trade Organization.
The Standards Network is currently working with the
EPA Trade and Environment Task Force, administered
through the Office of Policy, Planning, and Evaluation
(OPPE), to address such concerns and provide policy
guidance on these issues to program offices and to EPA
members of the ISO 14000 committees.
On behalf of EPA, OPPT is participating in the
development of the ISO 14000 standards. At the
annual ISO 14000 Technical Committee meeting in
Kyoto, Japan, OPPT representatives joined delegates
from around the world who gathered to continue their
work negotiating the development of the ISO 14000
standards. Some standards in the ISO 14000 series
have already been set. The 14001 standards on
management systems and its accompanying guidance
standards, 14004, along with the auditing standards are
already published and available. The 14001 standard
specifies commitment to "prevention of pollution" as a
required element of an organization's environmental
policy.
OPPT sees ISO 14000 as a pollution
prevention tool
Pollution prevention goals and the National
Technology Transfer and Advancement Act of 1995
(NTTAA) drive OPPT's involvement in ISO 14000.
EPA prefers innovative strategies including processes,
technologies, or management practices mat prevent
rather than control pollution.
OPPT views environmental management standards like
ISO 14000 as a potentially powerful tool to achieve
pollution prevention goals. NTTAA requires all
federal agencies to use voluntary standards in
procurement and regulatory activities as a means of
carrying out policy objectives or other actions, unless
the use of these standards would be inconsistent with
applicable law or impracticable. In addition, agencies
must participate in the development of voluntary
standards when such participation is in the public
interest.
OPPT feels ISO 14000 presents the opportunity for
industry to cost effectively accomplish the goals of
pollution prevention via a multi-media approach
that can integrate business goals and environmental
objectives. OPPT is working with a variety of
stakeholders to develop methods for verifying
environmental performance goals in such areas as
compliance and pollution prevention that result from
application of an environmental management system.
In order to better represent national needs in ISO
14000 activities, EPA is coordinating with many
groups to incorporate the perspectives and needs of
various sectors. Two EPA representatives participate
in a Multi-State Work Group (MSWG) for ISO 14001,
the standard for management systems.
The MSWG is developing a matrix of performance
indicators to test the impact of an ISO 14001-based
EMS in a variety of pilot projects across ten states.
Project designers will use the matrix to record data,
which will be included in a national data base of
information drawing on measurements from across
media, across states and across pilot projects.
Pollution prevention indicators are a major section of
the matrix. In addition, the MSWG draws upon the
enforcement and compliance matrix of indicators
currently under development by EPA's Office of
Enforcement and Compliance Assurance.
OPPT is also working with the National Pollution
Prevention Roundtable to develop segments on
pollution prevention that can be incorporated into ISO
14000 training courses. The Roundtable and OPPT
hope to gradually introduce the pollution prevention
hierarchy into the normal, accepted approach that any
organization would take in order to meet the
requirement of the standard. The 1990 Pollution
Prevention Act defines pollution prevention as source
reduction which is the most preferred activity in a
hierarchy. The pollution prevention hierarchy affirms
the principles of preventing pollution at the source
rather than controlling it once it is created, and of
reusing or recycling goods when possible, so that we
rely upon treatment and safe disposal as a final
alternative.
17
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Chemicals in the Environment
Spring/Summer 1997
Pollutant Release and Transfer Registers (PRTRs): International Toxics
Release Inventories
John Harman, Environmental Assistance Division, OPPT
The Toxics Release Inventory (TRI) has been a great
success for informing the American public about the
chemicals in their communities. However, the United
States is not the only country with a publicly available
inventory of toxic chemical releases and transfers. In
fact, the number of countries which have created these
systems, or which are in various stages of developing
them, is growing each year.
The names of these inventories vary from country to
country. While in the United States this inventory is
known as the Toxics Release Inventory (TRI), in
Canada it is the National Pollutant Release Inventory
(NPRI), and the Registro de Emisiones y Transferencia
Contaminantes (RETC) in Mexico. With so many
names addressing the same type of system, a standard
international name was selected, the Pollutant Release
and Transfer Register (PRTR).
The international momentum on PRTRs began
following the United Nation's 1992 Earth Summit
(more formally known as the United Nations
Conference on Environment and Development).
Among the conclusions resulting from the conference
was the value of PRTRs hi the sound management of
chemicals, and the importance of public involvement in
environmental decision-making.
At the time, only the United States, with its TRI,
collected yearly data on chemical releases and transfers
and made that information available to the public. The
Netherlands had been collecting air and water data on
a periodic basis since the early 1980s, but only
providing aggregate data to the public. Canada was hi
the process of creating its system.
One of the proposals from the Earth Summit was the
creation of a guidance document for governments on
PRTRs. The Organization for Economic Cooperation
and Development (OECD), of which the United States
is an active member, agreed to undertake this task. The
process of developing this PRTR Guidance Manual for
Governments, a document designed to facilitate the
Right to Know concept, itself highlighted the benefits
of public involvement. In a novel approach for the
OECD, industry, and other non-governmental
organizations were heavily involved hi the process,
providing important perspectives to the deliberations.
In fact, the speed and success at which the guidance
document was written prompted the environmental
ministers of the OECD to issue a Council
Recommendation encouraging all OECD nations to
create PRTRs.
Another decision from the Earth Summit was the need
to assist industrializing nations to develop PRTRs. The
United Nations Institute for Training and Research
(UNITAR) took on this role. UNITAR identified three
industrializing nations (Czech Republic, Egypt,
Mexico) to serve in a pilot project on PRTRs.
Using the OECD guidance manual, and a step by step
process with accompanying documents developed by
UNITAR, these countries began establishing national
PRTRs. The United States provided financial and other
forms of assistance to UNITAR on this project. With
the lessons learned from this process, UNITAR expects
to help other developing nations in the future.
A new player is the Commission for Environmental
Cooperation (CEC), an organization created by a side
agreement to the North American Free Trade
Agreement (NAFTA). Wirn PRTR systems operating,
or soon to be, in Canada, Mexico and the United States,
North America offers groundbreaking opportunities.
Release and transfer data now can be compiled between
neighboring nations.
North America will be the first instance in which
continent-wide PRTR data will be available. To take
advantage of this, the CEC is preparing two annual
documents. One analyzes the structure of the three
PRTR systems. A second compiles and compares the
PRTR data from the U.S. and Canada. Mexican data
will be included in the future. Both of these reports
18 —
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Issue No.
actually build on an EPA document that looks at PRTR
data along the U.S.-Canada border and the U.S.-Mexico
border. In addition, EPA's Region 5 and Environment
Canada have prepared reports which analyze PRTR
data around the Great Lakes. Beyond reports, the CEC
is also coordinating tri-national meetings to discuss
compatibility issues for the three PRTRs and is
providing assistance to Mexico on its PRTR
development.
Among the more recent events is the renewed
endorsement of PRTRs at the recent meeting of the
Intergovernmental Forum on Chemical Safely (IFCS).
The IFCS is responsible for overseeing international
progress on the action items relating to chemicals
management that grew out of the Earth Summit. The
U.S. and Mexico presented the IFCS with a paper on
PRTRs which outlined future PRTR projects and
sought recognition for the excellent work already
achieved. All the proposals in the paper were accepted
by the IFCS, which will probably stoke even greater
interest from industrializing nations.
The IFCS also encouraged the continued work
of the existing PRTR Coordination Group.
This group formed in 1996 to help
shepherd PRTR work and avoid a
duplication of efforts. Members
include the U.S. and other interested
OECD nations, plus representatives
from the OECD, the CEC, the
European Union (EU), and
UNITAR.
With the number of existing PRTRs growing from the
present six (Canada, France, Netherlands, Norway,
United Kingdom, U.S.), and with an increasing number
of PRTRs under development (Australia, Czech
Republic, EU, Egypt, Finland, Japan, Mexico, Sweden,
Switzerland), or under consideration (China, Hungary,
South Africa, Vietnam), this coordinating group is
essential.
Future activities will take advantage of the growing
experience on PRTRs. The most immediate event will
be the PRTR workshop for the Americas. Mexico will
host this workshop in July 1997, with the assistance of
the CEC, OECD, and UNITAR. Representatives from
governments and non-governmental organizations
(NGOs) from the nations in the Americas will attend.
Two similar workshops already have been held in
Australia for Asian and Pacific countries and in the
Czech Republic for the Central and Eastern European
nations. In 1998, Japan will host an OECD workshop
on PRTRs which will feature studies analyzing impacts
to industry and the public of existing PRTRs.
UNITAR will continue to work with industrializing
nations, moving from the present three pilot nations to
a new, as yet unchosen, group. Other international
organizations also are beginning to participate,
including the United Nations Environment Programme,
the World Bank, and the World Health Organization.
With so many players bringing so many new ideas, the
potential uses and benefits of PRTRs will continue to
unfold.
The Commission for Environmental Cooperation: A North American
Approach to Environmental Concerns
Lin Moos, National Program Chemicals Division, OPPT
The Commission for Environmental Cooperation
(CEC) facilitates cooperation and public
participation in fostering conservation,
protection, and enhancement of the North
American environment for the benefit of present
and future generations. This effort is particularly
important in the context of increasing economic
trade and social links between Canada, Mexico, and
the United States.
The CEC was established by the North American Free
Trade Agreement (NAFTA) countries in 1994 to
address environmental concerns in
North America regardless of national
boundaries. While the idea to create
such a commission originated during
the negotiations of the NAFTA, it
derives its formal mandate from the
North American Agreement for
Environmental Cooperation (NAAEC,
or the Agreement). The Agreement creates a North
American framework whereby trade and environment-
related goals can be pursued in an open and cooperative
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Chemicals in the Environment
Spring/Summer 1997
way and helps prevent the creation of trade distortions
or new trade barriers between the NAFTA partners.
In broad terms, the NAAEC sets out to protect,
conserve and improve the environment for present and
future generations by agreeing to a core set of actions
and principles, including:
• reporting on the state of the environment;
• effective enforcement of environmental law;
• improved access to environmental information;
• striving for improvement of environmental laws
and regulations; and
• promoting the use of economic instruments to
achieve environmental goals.
While a number of Resolutions have been adopted
under the Agreement, the Office of Prevention,
Pesticides, and Toxic Substances (OPPTS) has been
most actively involved in Council Resolution #95-5,
Sound Management of Chemicals. The Resolution was
developed because the three countries recognized that
they must cooperate to protect and improve the
environment and to achieve sustainable development.
A major and shared concern are chemical pollutants
transported across national boundaries through air and
watersheds and traded products.
Given the problems and lost opportunities that can arise
from the unsound use of chemicals, Canada, Mexico,
and the United States agreed to work cooperatively to
improve the management of chemicals while building
upon their respective national, bilateral, and
international commitments.
The first four substances addressed under the Sound
Management of Chemicals Program were
polychlorinated biphenyls (PCBs), mercury, DDT, and
chlordane. Action Plans for PCBs, DDT, and chlordane
are expected to be signed in June 1997 by EPA
Administrator Browner, Sergio Marchi, Canada's
Minister of the Environment, and Julia Carabias Lillo,
Mexico's Secretary of State for the Environment,
Natural Resources and Fisheries. The Action Plan for
mercury will follow later in the year.
Further information on the Commission for
Environmental Cooperation and ongoing activities under
NAAEC can be obtained from the CEC website at:
http://www.cec.org
Governments as Green Customers: Using Public Purchasing Power to
Improve the Environment
Eun-Sook Goidel, Pollution Prevention Division, OPPT
The Office of Pollution Prevention and Toxics (OPPT)
has been playing an active role in an international
forum created under the backing of the
Organization for Economic Cooperation and
Development (OECD) to facilitate information
exchange among countries on ways government
can use its purchasing power — at the Federal,
state and local levels — to achieve
environmental improvement.
Government purchasing represents a large
portion of most countries' economies and can
represent, in some cases, as much as 20% of
the Gross Domestic Product (GDP). In the
United States, the Federal government
purchases over $200 billion worth of goods
and service annually. The addition of state
and local government purchases nearly triples
this figure. Increasingly, policymakers hi
many countries are developing and
implementing innovative programs aimed at leveraging
the public sector's tremendous purchasing power as a
means to influence the marketplace towards greener
products and services.
Members of the international forum were
instrumental in setting the agenda for an
international conference on "greener" public
purchasing which the Government of Switzerland
recently sponsored. The conference brought
together over 130 participants from government,
industry and non-government organizations —
representing over 20 countries as well as a
number of international organizations, such as the
United Nations Development Program — to
share information on best practices
internationally. The conference highlighted a
variety of approaches, issues that cut across
national boundaries, as well as future areas for
international collaboration.
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Issue No. 4
Public Access Information
Programs to achieve environmental gains through
changes in public purchasing patterns vary widely, both
in terms of who initiates such activities and the types of
products covered (spanning from office equipment,
cleaning products, construction materials, to. even
services). In Denmark, for example, the central
government established a national strategy to "promote
sustainable product procurement." On the other hand,
in Switzerland, efforts have been much more diffuse,
with the cantons (similar to states) taking an active role
in promoting greener public purchasing in the absence
of a national policy.
The extent to which an individual country's "greener"
public purchasing programs are linked to a national
eco-labeling schemes also varies across national
boundaries. Some countries, such as Germany with its
Blue Angel eco-labeling program, have close linkages.
In the U.S., a series of Presidential Executive Orders
issued by President Clinton have fueled much of the
recent green purchasing activity. OPPT's own
Environmentally Preferable Purchasing Program is an
outgrowth of Executive Order 12873 on Federal
Acquisition, Recycling and Waste Prevention. This
Executive Order directs the Federal government to take
a leadership role in identifying and purchasing
"greener" products and services.
Pilot efforts in "greener" public purchasing are being
undertaken by the Department of Defense (construction
materials) and the General Services Administration
(cleaning products and latex paints), both in partnership
with EPA. Some very innovative programs have also
cropped up at the state and local government levels (for
example, by the Commonwealth of Massachusetts and
the City of Santa Monica, California, respectively).
Despite the diversity of approaches among the countries,
many of the programs share common challenges and
issues. There is a general consensus among countries
that a "greener" public purchasing program should take
into account environmental impacts associated with a
product's manufacture, use, and disposal, rather than just
focusing on one aspect of the product's life cycle.
Though a more comprehensive approach is seen as
desirable, implementing such an approach has been a
challenge for most programs — including OPPT's
Environmentally Preferable Products Program.
However, countries are trying a variety of innovative
methods to better integrate life cycle concepts into
purchasing programs and much can be learned by
sharing the experiences from these attempts.
Tremendous environmental gains can be made through
the concerted efforts of national, state and local
governments to factor in environmental considerations
in their purchasing decisions. To achieve global as well
as more local environmental improvements will require
close collaboration among environmental and
procurement experts as well as among countries so that
one country's environmental improvement is not gained
at the expense of another's.
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Chemicals in the Environment
Spring/Summer 1997
Non-Regulatory Initiatives and the Use of "Clusters" for Chemical Risk
Reduction: An OECD Workshop
Franklyn Hall, Chemical Engineering Branch, Economics, Exposure, and Technology
Division, OPPT
On September 10-13, 1995, the Organisation for
Economic Cooperation and Development (OECD) held
a workshop in Crystal City, Virginia. The purpose
of this workshop was to discuss the role of
voluntary initiatives and the use of "clusters" of
similar chemicals to promote pollution
prevention and cost-effective chemical risk
management.
OECD is a group of the world's
most highly industrialized and
developed nations. The member
countries of this organization work together on
issues such as trade, the environment, and
economic policy. In the environmental field,
OECD has worked to promote international standards
for screening level environmental information and
achieved international agreements on reducing risk
from certain chemicals such as lead.
Voluntary initiatives were identified as an effective
way to empower private industry in pollution
prevention and chemical risk management efforts. The
first two and a half days of the workshop consisted of
open discussions regarding voluntary initiative
programs from member countries and private industry.
These discussions helped to develop what the OECD
thinks are important first steps in the initial
development of a non-regulatory chemical risk
management and pollution prevention program.
Conference participants discussed the most important
steps in building a non-regulatory program, such as
clearly identifying and understanding goals, involving
stakeholders early, developing methods of measuring
success, and ensuring a clear understanding of how a
non-regulatory program can work with regulatory
programs. These key ingredients were identified as
necessary for the acceptance and success of voluntary
pollution prevention and chemical risk management
programs.
Recently, several OECD countries have expressed an
interest in having an open forum to consider ways to
manage chemicals through means other than chemical
by chemical. One such means would be to consider
clusters (that is, groups) of chemicals that are used
for the same purpose, such as paint strippers.
The OECD workshop also focused on using this
chemical "use cluster" approach as an alternative to
the single chemical approach. The forum brought out
issues regarding the cluster approach
and developed a pool of information.
This information will be considered
by OECD member countries to improve
their own chemical management
methodologies.
A number of concerns surfaced during this
forum. One concern addressed the need for member
countries to explore the potential for pollution
prevention and risk management benefits of all of a
chemical's uses before taking regulatory action on a
given chemical. Another concern was that the cluster
approach may discourage the risk assessment of
individual chemicals instead of promoting the risk
assessment of cluster chemical constituents.
In response to both concerns the general feeling was
that the cluster approach should be used as a means to
collect information for better risk-based decision
making. Member countries decided to investigate the
different applications of the cluster approach and to
request member countries to discuss how they are using
"cluster type" approaches. They also decided to
explore the possibilities of clustering as a basis for risk-
based assessments and risk-based chemical
management.
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Issue No. 4
Public Access Information
Sharing Information on New Chemicals: The United States/Canada Four
Corners Agreement
Anna Coutlakis, Chemical Control Division, OPPT
and David DiFiore, Economics, Exposure, and Technology Division, OPPT
Background
In an era of downsizing and belt-tightening, companies
are trying to increase efficiency and save resources any
way they can. When the Canadian government revised
its new chemicals review program — adding a
domestic substances inventory and production-based
testing requirements — cost-conscious companies
doing business in both the U.S. and Canada turned what
first appeared as yet another hurdle to marketing their
chemicals into a savings opportunity.
If a company had already sent a
chemical through the U.S. new
chemicals review, why not ask the
Canadians to consider the U.S. assessment
of its chemical? If the Canadian
government accepted the U.S. assessment, it
could save the company much in time and
testing costs. Such a system might also
make the Canadian reviewers' life simpler,
since they might benefit from the U.S.'s
review.
The Agreement
In 1994 the U.S., Canada and groups representing the
chemical industry in both countries initiated talks to
establish an information sharing system for new
chemicals that have gone through the U.S. review but
are not yet on the Canadian chemical inventory. After
two years of discussions, the U.S. EPA and
Environment Canada signed the "Four Corners
Agreement5' ("four corners" refers to the four principal
parties involved in the negotiations and in
implementing the agreement: the U.S. EPA,
Environment Canada, the U.S. chemical industry, and
the Canadian chemical industry).
Under the agreement, the parties began a two-year pilot
program in April 1996. The goal of the pilot is to
demonstrate that information sharing saves resources—
for industry and government—and that through U.S.
sharing of its assessment, new industrial chemicals can
enter the Canadian market faster and with fewer test
costs.
How It Works
Under the agreement, a new chemical manufacturer
seeking entry to the Canadian market would begin the
information-exchange process by submitting a request
to Environment Canada. The Canadians would then
notify the U.S. EPA's New Chemicals Program of the
request, which would include information on the
specific chemical for which information is sought and
other relevant identifiers. Before any information can
be released to Environment Canada, the U.S. EPA
must receive a written waiver from the company,
typically the U.S.-based parent of a Canadian
subsidiary, that had submitted the chemical for
review in the U.S. After receipt of the
waiver, the EPA would send the
documents from its assessment to
Environment Canada.
The Canadians use this information as one
element of their overall assessment of the new
chemical. If they have questions about the U.S.
review or need additional information, Canadian
reviewers are free to contact assessors at EPA.
Once the Canadians complete their review, they
decide whether to allow the new chemical on their
inventory, request additional information or testing, or
deny the request for inventory status.
Whatever the outcome, Environment Canada informs
EPA of its decision. If the Canadians have received
test data on the chemical that was not part of the U.S.
review, that information is sent to EPA, as well as any
data Environment Canada obtains in the future.
What's Happened
To date, EPA has shared information on 25 chemicals,
submitted by eleven U.S. chemical companies.
Cooperative and productive interactions between EPA
and Environment Canada bode well for the future of
this agreement. A successful Four Corners program
not only enhances commerce between the U.S. and
Canada, but furthers international efforts to harmonize
and streamline the assessment and introduction of new
chemicals. Both the 1992 United Nations Conference
23
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Chemicals in the Environment
Spring/Summer 1997
on Environment and Development in Rio de Janeiro
and more recent Organizalion for Economic
Cooperation and Development workshops in Paris
sought progress on the goal of harmonizing new
chemical reviews.
Ultimately, the Four Corners Agreement illustrates
that government and industry can work together to
find practical solutions that promote efficiency and
save dollars — both American and Canadian.
Measuring Air Pollution in the Great Lakes Region
Gary Gulezian, Acting Director, EPA Great Lakes National Program Office
Scientists at the U.S. Environmental Protection Agency
(EPA) are measuring the levels of many man-made
chemicals in the air in the Great Lakes area to evaluate
whether a large amount of these chemicals is getting
into the waters of the Great Lakes from the air. The
chemicals being measured are of concern because they
are found in the fish of the Great Lakes and can pose a
health hazard to people who eat Great Lakes fish.
Some of these chemicals are:
polychlorinated biphenyls (PCBs), industrial
chemicals widely used until production was
stopped in 1977;
DDT, an insecticide used for termite control until
it was banned in 1972;
mercury, a naturally occuring element often used in
electrical equipment and thermometers;
Undone, an insecticide used on food crops and
forests, and to control lice and scabies in
livestock and humans; most uses were restricted
in 1983;and
polycyclic aromatic hydrocarbons (PAHs),
compounds emitted by combustion facilities such
as waste incinerators.
To measure these chemicals, EPA, in cooperation with
Environment Canada, established a binational air
49-
47-
45-
43-
41
I I I
,L. Superior IADN
Master Stations
Satellite Stations
-93
-89
-85
-81
-77
Longitude (W)
Figure: Integrated Atmospheric Deposition Network (IADN) Monitoring Stations
24
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fssue No. 4
Public Access Information
monitoring network called the Integrated Atmospheric
Deposition Network (IADN). The IADN is made up of
five primary, or "master," monitoring stations, one on
each Great Lake, and fourteen supplemental, or
"satellite," stations that provide additional information
(see Figure, p.24). This network is required by the
Great Lakes Water Quality Agreement, a binational
agreement to reduce toxic chemicals in the Great
Lakes.
At each IADN site, concentrations of chemicals are
measured in rain and snow (also called wet deposition),
airborne particles (dry deposition), and airborne
vapors. From these measurements, the amount of a
chemical entering the lake from the air can be
estimated. Since its inception in 1990, IADN has
tracked trends of chemical concentrations in air. For
example, IADN data have shown that levels of lead
entering the Great Lakes from the air declined from
1990 to 1994. This is probably due to the removal of
lead in most vehicle fuels in the U.S. Another example
is that the level of PCBs in the air of the Great Lakes
region seems to remain fairly constant, perhaps
showing a slight decline, but not a large one. This is of
concern since PCBs were phased out in the 1970's, but
are still found in our environment at elevated levels.
If you would like information on IADN, please contact
the EPA project manager, Angela Bandemehr, at (312)
886-6858 or via e-mail at:
bcmdemehr.angela@epamaiL epa.gov.
The International ToxicologicaS Profiles Collection of the Office of Pollution
Prevention & Toxics Library
Linda Miller Poore, M.L.S., Head Librarian, Office of Pollution Prevention and Toxics Library
(operated for OPPT by Garcia Consulting, Inc.)
in German, but Chemical Abstracts Service registry
numbers are provided. The Library carries the English
language versions of the BUA reports.
An older title is the United Nations Environment
Programme's International Register of Potentially Toxic
Chemicals (IRPTC) collection of the Scientific Reviews
of Soviet Literature on Toxicity and Hazards of
Chemicals. This series is aimed at "toxicologists,
The United States Centers for Disease Control &
Prevention (CDC), Agency for Toxic Substances and
Disease Registry (ATSDR) publishes a useful set of
guides to the health effects of toxic chemicals in its
Toxicological Profiles series. But other countries and
international organizations also produce similar
volumes, some of which are collected by the U.S.
EPA's Office of Pollution Prevention and Toxics
Library and are described below.
The Government of Canada requires under its Canadian
Environmental Protection Act (CEPA), that the
Minister of Environment and the Minister of Health
prepare and publish assessments as to the toxicity of a
Priority Substances List, which identifies chemicals,
groups of chemicals, effluents, and wastes that may be
harmful to the environment or a danger to human
health. The Library carries the series of Priority
Substances List Assessment Reports that seek to
determine the toxicity of the substance being examined.
The next country-specific titles are the German
Chemical Society Advisory Committee on Existing
Chemicals of Environmental Relevance
(Beratergremium fur Umweltrelevante Altstoffe
(BUA)) report series which utilize published scientific
literature as well as data from industry. A list of
available titles is included on their website. The site is
Chemical Information Contained in BUA
Reports (BUA-Stoffberichte)
A standard BUA report includes the following sections:
Summary and Conclusions
Recommendations
Chemistry
Physical Properties
Emission into the Environment during Production
Processing
Use and Waste Disposal
Environmental Occurrence
Environmental Behavior
Ecotoxicity
Toxicity to Warm-Blooded Animals
Substance-Specific Legal Regulations
a Reference/Literature list
25
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Chemicals in the Environment
Spring/Summer 1997
hygienists and those responsible for evaluation and
control of harmful effects of chemicals to human health
and the environment." Published in the 1980s, this
English language series is now primarily valuable as a
historical resource.
The European Centre for
Ecotoxicology and Toxicology of
Chemicals (ECETOC),
headquartered in Brussels,
Belgium, produces three peer-
reviewed series: Monographs,
Technical Reports, and the Joint
Assessment of Commodity
Chemicals (JACC) Report series.
Commodity chemicals are defined as
produced in large tonnage by several companies and
having widespread and multiple uses." (Note: The
JACC series/reports cover only the chemical itself and
not products in which it may occur as an impurity.)
Finally, the International Programme on Chemical
Safety (IPCS), under the joint sponsorship of the
United Nations Environment Programme (UNEP), the
International Labour Organisation, and World Health
Organization (WHO), contributes two titles to the
"those
OPPT Library toxicological profiles collection: the
Environmental Health Criteria (EHC) chemical profile
monographs and companion Health and Safety Guides.
Besides chemical-specific volumes, the EHC series
includes titles devoted to evaluating toxicological
methodologies for genetic, neurotoxic, teratogenic and
nephrotoxic effects; epidemiological
guidelines; evaluation of short-term tests for
carcinogens; biomarkers; and effects on
specific populations such as the elderly.
The target audience for the EHC
monographs are national and
international authorities responsible for
conducting risk assessments and
making risk management decisions,
while the less technical Health and Safety Guides are
meant to provide practical information on how to safely
use chemicals and avoid creating environmental health
hazards.
For further information on borrowing any of these titles
through Interlibrary Loan, contact your local
library or the OPPT Library. Telephone: (202)
260-3944; FAX (202) 260-4659; E-mail:
library-tsca@epamail.epa.gov
internet addresses for organizations and publications listed above
Agency for Toxic Substances andDisease Registry http://aisd[rI.afsdncdckgavi8080Msdrliome.Iitmi
(ATSDR) .
Environment Canada
Commercial Chemicals Website
Priority Substances Assessment Program..
European Centre for EcotoxicologyandToxicology of
Chemicals (ECETOC)
German Chemical Society {GeseHsehaft Deatscher
Chemiker) Advisory Committee an Existing Chemicals
of Environmental Relevance (Beratergremium Sir
Umweltrelevante Altstofie (BUA»
International Programme on Chemical Safety (iPCS)
Scientific Reviews of Soviet Literature on Tenacity and
Hazards of Chemicals (UNEP/IRPTC)
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